12 Amendments of Horst SCHNELLHARDT related to 2012/0266(COD)
Amendment 154 #
Proposal for a regulation
Recital 8
Recital 8
(8) It should be the responsibility of the Member States to decide on a case-by-case basis whether or not a product falls within the scope of this Regulation. If necessary, the Commission may decide, on a case-by- case basis, whether or not a product falls within the definition of a medical device or of an accessory to a medical device. In the interests of legal certainty, clear reasons should be given for such decisions and the manufacturers concerned should be consulted as part of the decision-making process. Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the possibility to take an EU- wide decision regarding the regulatory status of a product should also be introduced in Regulation No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
Amendment 273 #
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. The Commission may, at the request of a Member State or on its own initiative and following consultation with the manufacturer in question on the basis of concerns about patient safety or in the light of new scientific findings, by means of implementing acts, determine whether or not a specific product, or category or group of products, falls within the definitions of 'medical device' or 'accessory to a medical device'. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
Amendment 390 #
Proposal for a regulation
Article 15 – paragraph 2 a (new)
Article 15 – paragraph 2 a (new)
2a. The Commission, by means of implementing acts, shall lay down guidelines on the reprocessing of medical devices, with stipulations on standardisable, reproducible and effective cleaning, disinfection and sterilisation processes in line with the risk assessment for the respective devices, as well as requirements in relation to systems for hygiene, infection-prevention, quality management and documentation applicable to the natural or legal persons reprocessing the medical devices. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
Amendment 398 #
Proposal for a regulation
Article 15 – paragraph 4
Article 15 – paragraph 4
4. The Commission, by means of implementing acts, shall establish and regularly update a list of categories or groups of single-use devices for critical use which may be reprocessed in accordance with paragraph 3. The list shall also include requirements in relation to systems for hygiene, infection- prevention, quality management and documentation applicable to the natural or legal persons reprocessing these particularly sensitive devices. It will be regularly updated. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
Amendment 400 #
Proposal for a regulation
Article 15 – paragraph 6
Article 15 – paragraph 6
Amendment 495 #
Proposal for a regulation
Article 32 – paragraph 3
Article 32 – paragraph 3
3. Within 14 days of the submission referred to in paragraph 2, the Commission shall designate a joint assessment team made up of at least twohree experts chosen from a list of experts who are qualified in the assessment of conformity assessment bodies. The list shall be drawn up by the Commission in cooperation with the MDCG. At least one of these experts shall be a representative of the Commission who, and at least one other shall come from a Member State other than that in which the applicant conformity assessment body is established; The Commission representative shall lead the joint assessment team.
Amendment 496 #
Proposal for a regulation
Article 32 – paragraph 4 – subparagraph 2
Article 32 – paragraph 4 – subparagraph 2
Findings regarding non-compliance of a body with the requirements set out in Annex VI shall be raised during the assessment process and discussed between the national authority responsible for notified bodies and the joint assessment team with a view to finding common agreement with respect to the assessment of the application. Divergent opinions shall be identified inIn the event of a disagreement, a separate opinion drawn up by the assessment team setting out its reservations regarding notification shall be appended to the assessment report of the national authority responsible.
Amendment 497 #
Proposal for a regulation
Article 32 – paragraph 5
Article 32 – paragraph 5
5. The national authority responsible for notified bodies shall submit its assessment report and its draft notification to the Commission which shall immediately transmit those documents to the MDCG and to the members of the joint assessment team. If the assessment team draws up a separate opinion, this too shall be submitted to the Commission for forwarding to the MDCG. Upon request by the Commission, those documents shall be submitted by the authority in up to three official Union languages.
Amendment 498 #
Proposal for a regulation
Article 32 – paragraph 6
Article 32 – paragraph 6
6. The joint assessment team shall provide its final opinion regarding the assessment report and, the draft notification and, where appropriate, the separate opinion drawn up by the assessment team, within 21 days of receipt of those documents and the Commission shall immediately submit this opinion to the MDCG. Within 21 days after receipt of the opinion of the joint assessment team, the MDCG shall issue a recommendation with regard to the draft notification which the relevant national authority shall duly take into consideration for its decision on the designation of the notified body. If, in taking its decision, the relevant national authority goes against the MDCG's recommendation, it must outline its reasons for so doing to the Commission in writing.
Amendment 559 #
Proposal for a regulation
Article 44
Article 44
Amendment 669 #
Proposal for a regulation
Article 67 – paragraph 1
Article 67 – paragraph 1
1. The competent authorities shall perform appropriate checks on the characteristics and performance of devices including, where appropriate, review of documentation and physical or laboratory checks on the basis of adequate samples. They shall take account of established principles regarding risk assessment and risk management, vigilance data and complaints. The competent authorities may require economic operators to make available the documentation and information necessary for the purpose of carrying out their activities and, where necessary and justified, and also without announcing their intention, enter the premises of economic operators and take the necessary samples of devices. They may destroy or otherwise render inoperable devices presenting a serious risk where they deem it necessary.
Amendment 674 #
Proposal for a regulation
Article 67 – paragraph 2
Article 67 – paragraph 2
2. The Member States shall periodically plan, review and assess the functioning of their surveillance activities. SuchTo this end, Member States shall draw up strategic monitoring plans which lay down a risk classification, surveillance intervals, the nature of the surveillance measures and the human and material resources to be used to carry out the monitoring. A reviews and assessment of the activities shall be carried out at least every four years and the results thereof shall be communicated to the other Member States and the Commission. The Commission may make recommendations for adjustments to the monitoring plans. The Member State concerned shall make a summary of the results and of the Commission’s recommendations accessible to the public.